A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Systemic Lupus Erythematosus
Trial Parameters
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Brief Summary
This study is a randomized, controlled, phase I clinical study with safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics in patients with systemic lupus erythematosus.
Eligibility Criteria
Inclusion Criteria: 1. Subjects can understand the informed consent form, voluntarily participate in and sign the informed consent form; 2. No gender limit; 3. Age: ≥18 years old and ≤75 years old; 4. Life expectancy greater than 6 months; 5. SLE was diagnosed according to the 2019 EULAR/ACR revised criteria; 6. Patients with moderate to severe systemic lupus erythematosus, SLEDAI-2K score \> at screening; 7 points; 7. A stable standard-of-care regimen was maintained for at least 30 days before the first dose; 8. ANA ≥ 1:80 or anti-dsdna antibody higher than the upper limit of normal range (ULN) as determined by central laboratory at screening; 9. The presence of CD19+ B cells in the peripheral blood of the patient; 10. The organ function level before the first administration met the requirements; 11. Female subjects of childbearing potential or male subjects with a fertile partner must use highly effective contraception from 7 days before the first dose until 24 weeks after the term